PMID- 21277674
OWN - NLM
STAT- MEDLINE
DCOM- 20110725
LR  - 20131121
IS  - 1872-7654 (Electronic)
IS  - 0301-2115 (Linking)
VI  - 155
IP  - 2
DP  - 2011 Apr
TI  - Contraceptive efficacy of a combined oral contraceptive containing 
      ethinyloestradiol 20 mug/drospirenone 3mg administered in a 24/4 regimen: a pooled 
      analysis of four open-label studies.
PG  - 180-2
LID - 10.1016/j.ejogrb.2010.12.037 [doi]
AB  - OBJECTIVE: To determine the contraceptive efficacy of a low-dose combined oral 
      contraceptive containing ethinyloestradiol (EE) 20 mug/drospirenone (drsp) 3mg 
      administered for 24 days followed by a four-day hormone-free interval (24/4 
      regimen), by pooling data from four clinical trials. STUDY DESIGN: Data on the 
      occurrence of pregnancy during treatment in four open-label trials that enrolled 
      healthy female volunteers aged 17-36 years, who received EE 20 mug/drsp 3mg in a 
      24/4 regimen for 7 or 13 cycles, were pooled. RESULTS: Sixteen pregnancies 
      occurred among 2386 women during 729,537 days (26,055 cycles) of treatment 
      exposure, resulting in a Pearl Index (PI) of 0.80 (upper two-sided 95% confidence 
      interval (CI) limit of 1.30). Of these pregnancies, seven were defined as method 
      failures, resulting in an adjusted PI of 0.41 (upper two-sided 95% CI limit of 
      0.85), based on 616,607 days (22,022 cycles) of treatment. The Kaplan-Meier 
      estimate for the one-year cumulative probability of contraceptive protection was 
      99.21%. CONCLUSIONS: The EE 20 mug/drsp 3mg combined oral contraceptive 
      administered in a 24/4 regimen has acceptable contraceptive efficacy.
CI  - Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
FAU - Anttila, Leena
AU  - Anttila L
AD  - The Family Federation of Finland, Turku Clinic, Turku, Finland.
FAU - Bachmann, Gloria
AU  - Bachmann G
FAU - Hernadi, Laszlo
AU  - Hernadi L
FAU - Kunz, Michael
AU  - Kunz M
FAU - Marr, Joachim
AU  - Marr J
FAU - Klipping, Christine
AU  - Klipping C
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110201
PL  - Ireland
TA  - Eur J Obstet Gynecol Reprod Biol
JT  - European journal of obstetrics, gynecology, and reproductive biology
JID - 0375672
RN  - 0 (Androstenes)
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Estrogens)
RN  - 0 (Progestins)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - N295J34A25 (drospirenone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Androstenes/administration & dosage/*therapeutic use
MH  - Contraceptives, Oral, Combined/administration & dosage/*therapeutic use
MH  - Estrogens/administration & dosage/*therapeutic use
MH  - Ethinyl Estradiol/administration & dosage/*therapeutic use
MH  - Female
MH  - Humans
MH  - Medication Adherence
MH  - Pregnancy
MH  - *Pregnancy Rate
MH  - Progestins/administration & dosage/*therapeutic use
MH  - Statistics as Topic
MH  - Young Adult
EDAT- 2011/02/01 06:00
MHDA- 2011/07/26 06:00
CRDT- 2011/02/01 06:00
PHST- 2010/08/05 00:00 [received]
PHST- 2010/12/13 00:00 [revised]
PHST- 2010/12/28 00:00 [accepted]
PHST- 2011/02/01 06:00 [entrez]
PHST- 2011/02/01 06:00 [pubmed]
PHST- 2011/07/26 06:00 [medline]
AID - S0301-2115(11)00018-2 [pii]
AID - 10.1016/j.ejogrb.2010.12.037 [doi]
PST - ppublish
SO  - Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 
      10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1.